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A Pilot Study of Unrelated Umbilical Cord Blood Transplantation in Children and Adults With Hematologic Malignancies


Phase 2
N/A
54 Years
Not Enrolling
Both
Graft Versus Host Disease, Leukemia, Lymphoma, Myelodysplastic Syndromes, Neuroblastoma

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Trial Information

A Pilot Study of Unrelated Umbilical Cord Blood Transplantation in Children and Adults With Hematologic Malignancies


OBJECTIVES: I. Determine the rates of hematologic and immune reconstitution in pediatric
patients with high risk hematologic malignancies in first remission or in second or
subsequent remission, and adult patients with acute lymphocytic leukemia (ALL) or acute
nonlymphocytic leukemia (ANLL) in second or subsequent remission, who are undergoing high
dose chemoradiotherapy followed by unrelated umbilical cord blood (UCB) transplantation. II.
Determine the incidence of graft-versus-host disease in this setting. III. Determine whether
contamination of umbilical cord blood with maternal cells is a clinical problem in this
setting. IV. Describe the incidence of leukemic relapse in these patients after UCB
transplantation. V. Describe the incidence of serious infections and secondary
lymphoproliferative diseases following transplantation with UCB in these patients. VI.
Determine specifically whether larger recipients (greater than 40 kg) can be durably
engrafted with unrelated UCB, and determine whether nucleated cell or progenitor cell
content of the graft is predictive of hematological engraftment.

OUTLINE: Patients undergo a back-up bone marrow harvest prior to treatment. Patients receive
9 fractions of total body irradiation (TBI) on days -9 to -5, followed by melphalan IV on
days -4 to -2 and antithymocyte globulin IV or methylprednisolone IV on days -3 to -1. If
TBI is not allowed, busulfan is substituted and administered orally every 6 hours for 4 days
on days -8 to -5. On day 0, patients receive umbilical cord blood infusion. Cyclosporine and
methylprednisolone begin on day -2 and continue for 6 months. Patients are followed
indefinitely for survival and late toxicity.

PROJECTED ACCRUAL: A minimum of 48 patients will be accrued into this study within 4 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed malignancy including: - Pediatric acute
lymphocytic leukemia (ALL) in first complete remission with high risk features including
presence of t(4;11) or t(9;22), or extreme hyperleukocytosis (initial WBC greater than 500
K/mL), or failure to achieve a complete remission after standard induction therapy - Adult
ALL or acute nonlymphoblastic leukemia (ANLL) in first complete remission with t(8;14)
translocation or failure to achieve complete remission after standard induction therapy -
ALL or ANLL in second or subsequent remission - Chronic myelogenous leukemia in chronic or
accelerated phase - Myelodysplastic syndrome with evidence of evolution to acute myeloid
leukemia Refractory anemia with excess blasts Refractory anemia with excess blasts in
transformation Chronic myelomonocytic leukemia - T-lymphoblastic non-Hodgkin's lymphoma in
second or subsequent remission - Stage IV neuroblastoma Must also meet all the following
conditions: No HLA-ABC/DR identical related bone marrow or UCB donor No 5/6 antigen
matched related bone marrow or UCB donor Condition precludes waiting to search and find a
donor in the National Marrow Donor Registry Must have an available serologic matched
umbilical cord blood unit in the New York Blood Center's Placental Blood Project No active
CNS disease Not eligible for COBLT study (Transplantation of Banked Umbilicial Cord Blood
Cells for Use in Clinical Research on Transplantation of Umbilical Cord Blood Stem and
Progenitor Cells)

PATIENT CHARACTERISTICS: Age: Under 55 at time of umbilical cord blood transplantation
Performance status: Zubrod 0-1 Lansky 80-100% Karnofsky 80-100% Life expectancy: At least
3 months Hematopoietic: Adequate hematologic status at time of back-up bone marrow
harvest: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,000/mm3 Platelet
count at least 100,000/mm3 Hepatic: ALT/AST no greater than 4 times normal Bilirubin no
greater than 2.0 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Creatinine clearance at
least 50 mL/min Cardiovascular: Normal cardiac function by echocardiogram or radionuclide
scan (shortening fraction or ejection fraction at least 80% of normal value for age)
Pulmonary: FVC and FEV1 at least 60% of predicted for age For adults: DLCO at least 60% of
predicted Other: No active infections at time of back-up bone marrow harvest or
pretransplant reduction Not pregnant or nursing Negative pregnancy test Fertile patients
must use effective contraception HIV negative

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not
specified

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Barbara Jean Bambach, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000066754

NCT ID:

NCT00003661

Start Date:

June 1998

Completion Date:

March 2006

Related Keywords:

  • Graft Versus Host Disease
  • Leukemia
  • Lymphoma
  • Myelodysplastic Syndromes
  • Neuroblastoma
  • recurrent childhood acute lymphoblastic leukemia
  • stage 4S neuroblastoma
  • recurrent childhood lymphoblastic lymphoma
  • recurrent adult acute lymphoblastic leukemia
  • chronic phase chronic myelogenous leukemia
  • accelerated phase chronic myelogenous leukemia
  • adult acute myeloid leukemia in remission
  • adult acute lymphoblastic leukemia in remission
  • childhood acute myeloid leukemia in remission
  • childhood acute lymphoblastic leukemia in remission
  • refractory anemia with excess blasts
  • refractory anemia with excess blasts in transformation
  • chronic myelomonocytic leukemia
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent adult Burkitt lymphoma
  • de novo myelodysplastic syndromes
  • previously treated myelodysplastic syndromes
  • secondary myelodysplastic syndromes
  • graft versus host disease
  • adult acute minimally differentiated myeloid leukemia (M0)
  • childhood acute minimally differentiated myeloid leukemia (M0)
  • recurrent childhood small noncleaved cell lymphoma
  • recurrent childhood large cell lymphoma
  • recurrent mantle cell lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • childhood myelodysplastic syndromes
  • Graft vs Host Disease
  • Leukemia
  • Lymphoma
  • Myelodysplastic Syndromes
  • Preleukemia
  • Neuroblastoma

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Rush-Presbyterian-St. Luke's Medical CenterChicago, Illinois  60612
University of Chicago Cancer Research CenterChicago, Illinois  60637
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Medical University of South CarolinaCharleston, South Carolina  29425-0721
University of Florida Health Science CenterGainesville, Florida  32610-0296
North Shore University HospitalManhasset, New York  11030
Hackensack University Medical CenterHackensack, New Jersey  07601
Nemours Children's ClinicJacksonville, Florida  32207
Children's Hospital of New OrleansNew Orleans, Louisiana  70118
Cardinal Glennon Children's HospitalSaint Louis, Missouri  63104
St. Christopher's Hospital for ChildrenPhiladelphia, Pennsylvania  19134-1095
University of South Carolina School of MedicineColumbia, South Carolina  29203
Division of Pediatric SurgeryJacksonville, Florida  32207
New York Blood CenterNew York, New York  10021